Committee on Technical Barriers to Trade - Agreement reached by a Member with another country or countries on issues related to technical regulations, standards or conformity assessment procedures - Notification - Republic of Korea

AGREEMENT REACHED BY A MEMBER WITH ANOTHER COUNTRY OR COUNTRIES
ON ISSUES RELATED TO TECHNICAL REGULATIONS, STANDARDS
OR CONFORMITY ASSESSMENT PROCEDURES

NOTIFICATION

Under Article 10.7 of the Agreement "Whenever a Member has reached an agreement with any other country or countries on issues related to technical regulations, standards or conformity assessment procedures which may have a significant effect on trade, at least one Member party to the agreement shall notify other Members through the Secretariat of the products to be covered by the agreement and include a brief description of the agreement." The following notification under Article 10.7 has been received.

 

1.

Notifying Member: REPUBLIC OF KOREA

2.

Title of the bilateral or plurilateral Agreement: Annex 8C (Sectoral Annex on Good Manufacturing Practice for Medicinal Products) of the Free Trade Agreement between the Government of the Republic of Korea and the Government of the Republic of Singapore

3.

Parties to the Agreement: Republic of Korea; Singapore

4.

Date of entry into force of Agreement: 1 May 2024

5.

Products covered (HS or CCCN where applicable, otherwise national tariff heading): Medicinal products; Good manufacturing practice (GMP) inspection

6.

Subject matter covered by the Agreement (technical regulations, standards or conformity assessment procedures): Conformity assessment procedures

7.

Brief description of the Agreement: This Agreement lays down the conditions under which one Party will accept the pharmaceutical GMP conformity assessment results (e.g. GMP inspection certificates) performed by the other Party's competent authority, and vice versa. This Agreement applies to GMP medicinal products for human use and facilitates market access by eliminating technical barriers to trade with respect to medicinal products.

8.

Further information available from: Technical Barriers to Trade (TBT) Division

Korean Agency for Technology and Standards (KATS)

93, Isu-ro, Maengdong-myeon, Eumseong-gun, Chungcheongbuk-do, Republic of Korea, 369-811

Tel.: (+82) 43 870 5315 Fax: (+82) 43 870 5682

E-mail: tbt@kats.go.kr Website: http://www.knowtbt.kr

 

 

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